Beurer - Body Fat Scale - BEURER NORTH AMERICA, L.P.

Duns Number:078497467

Device Description: Body Fat Scale

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More Product Details

Catalog Number

Type BF220

Brand Name

Beurer

Version/Model Number

BF221 (Art.-No. 740.79)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PUH

Product Code Name

Analyzer, Body Composition, Exempt

Device Record Status

Public Device Record Key

8c02f8f8-058f-4e5f-a5e7-a6ebf15bfabc

Public Version Date

February 25, 2019

Public Version Number

4

DI Record Publish Date

March 15, 2017

Additional Identifiers

Package DI Number

10852547004266

Quantity per Package

4

Contains DI Package

00852547004269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack

"BEURER NORTH AMERICA, L.P." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 90
U Unclassified 2